In a judgement passed by the Supreme Court of India on January 08, 2019, an order of the Division Bench of the Delhi High Court was set aside. Earlier, the Division Bench’s order had held a key patent of Monsanto invalid. The patent is key to Monsanto’s Bollgard II Bt cotton business vertical. The Supreme Court primarily set aside the Bench’s order because the patent was held invalid in the absence of a trial, and the Supreme Court bought into the argument of Monsanto that it had not waived its rights for a trial in the matter of validity of its patent. Therefore, it is important to note that Supreme Court did not scrutinize the patent in question to declare the patent valid. The question of validity of the patent is likely to be dealt with in a trial court, and eventually the Supreme Court, given the stakes.

The suits concerning the current patent, and its eventual outcome will be extremely important to the biotechnology industry, and more specifically to agro-biotech industry. The decision on validity of the patent will have a major impact on what is considered patent eligible subject matter in the biotech industry. The decision may also hugely impact claim drafting and IP strategy that may be adopted to protect subject matter comparable to the one claimed in the patent.

The patent includes two sets of claims, 1-24 and 25-27. The first set of claims, 1-24, cover a method of producing a transgenic plant, whereas the second set covers a product, viz., a nucleic acid sequence. The independent method claim 1 includes the step of incorporating a Nucleic Acid Sequence (NAS) into the genome of a plant. The independent product claim 25 on the other hand claims the NAS. The method claim targets those companies, which prepare donor seeds that have NAS, and such companies are fewer in number. The claims which are relatively of substantial commercial value are the product claims 25-27. The product claims target those companies who prepare hybrid seeds, which are derived from a process involving the donor seeds comprising the claimed NAS. The hybrid seeds will include the NAS, and therefore read on the product claim.

While the validity of the process claim may be questioned, the parties who are up against Monsanto are more interested in invalidating the product claims. We will discuss later on in the article about the far-reaching impact of the product claims in question. The independent product claim 25 is reproduced below.

25. A nucleic acid sequence comprising a promoter operably linked to a first polynucleotide sequence encoding a plastid transit peptide, which is linked in frame to a second polynucleotide sequence encoding a Cry2Ab Bacillus thuringiensis 8-endotoxin protein, wherein expression of said nucleic acid sequence by a plant cell produces a fusion protein comprising an amino-terminal plastid transit peptide covalently linked to said 5-endotoxin protein, and wherein said fusion protein functions to localize said 5-endotoxin protein to a subcellular organelle or compartment.

The first part of the claim, appearing before the expression “wherein”, includes elements of the product (NAS), and the second part of the claim recites the consequence of its use.

The validity of the patent is challenged based on the provisions of § 3(j) of The Patents Act, 1970 (“Act”), which excludes patenting of plants and animals in whole or in part, seeds, varieties, species, and essentially biological processes for production or propagation of plants and animals. However, said section allows patenting of microorganisms.

The argument used to challenge the validity is that NAS by itself are inert and inanimate, and its only use is when the NAS is incorporated into a plant genome to form a seed or a plant, and seeds and plants are excluded subject matter.

We agree with the contention that NAS by itself are inert and inanimate, and its only use is when the NAS is incorporated into a plant genome to form a seed or a plant. However, we are not convinced that the Act, as it stands, allows for patent to be rejected or invalidated based on such contention.

In the above referred contention, it appears that it is not the subject matter of the claim, which is scrutinized to check whether it falls within the scope of excluded subject matter. Instead, the industrial application (which is not necessarily the subject matter of the claim) of the subject matter of the claim is scrutinized to check whether it falls within the scope of excluded subject matter. In our view, the subject matter and not the industrial application (when not considered part of the claim) of the subject matter, should be scrutinized to reject or invalidate a claim based on provisional of excluded subject matter.

We propose to use a few analogies to demonstrate the faults in the argument that a claimed subject matter should be classified as being within the scope of excluded subject matter if its only use or industrial application falls within the scope of excluded subject matter. In the first analogy, consider a tool that is developed for performing surgery. In this case the tool by itself is inert and inanimate, and its only use is in a surgical process, which is excluded subject matter under § 3(i). In another analogy, consider a pharmaceutical product that is developed to fight cancer. In this case again, the product by itself is inert and inanimate, and its only use is in a medical process (consumption of the drug as per a prescribed dosage), which is also excluded subject matter under § 3(i). Going by the argument based on “use”, both the surgical tool and the pharmaceutical product should be considered to fall within the scope of excluded subject matter. Therefore, if a patent is held invalid on the basis of “use”, there would be practically a blanket ban on patenting of pharmaceutical products, which is clearly not the legislative intent, given the amendments made to the Act in the past to comply with TRIPS.

Having made arguments in favour of upholding the validity of the patent, we now look at the challenge upholding the validity of the patent. At the outset, in our view, we believe that the patent is valid based on the provisions of the Act, since the subject matter as claimed doesn’t fall within the scope of excluded subject matter. It is important to note that it is the NAS that is claimed, and not the seed. Assuming that the claimed NAS is patent eligible, consider the potential infringers. Primarily, the hybrid seed companies who produce and sell seeds that include the claimed NAS are potential infringers, and so are farmers who use such seeds. Therefore, at present the farmers are at the mercy of the patent owner, who has gone against the hybrid seed sellers (companies) and not the users (farmers). While it is certain that no company will make the mistake of filing patent suit against farmers in India, given how politically sensitive such an action would be, there is noting in the Act that stops the patent owner from going against farmers.

Now the question is whether there is legislative intent expressed in the Act to shield farmers from patent suits. In our view, § 3(j) indirectly expresses the legislative intent to shield farmers from patent suits, to the extent the legislature could envisage patent threats to farmers. However, in our opinion, the protection offered by the language used in § 3(j) is inadequate. The exposure of farmers to patent suits is well known by examples in foreign countries, and the legislature should make amendments to the Act at least now, instead of assuming that patent suits are unlikely to be filed against farmers in India.

The amendment to shield farmers could be made by altering the language of § 3(j). However, we believe that such an amendment could lead to more complications. Instead, the Act may be amended, say by adding a clause to § 47, to exclude certain acts by farmers from being considered patent infringement. The reason why we propose to add a clause to exclude farmers, rather than amend the language of § 3(j), is because, we believe that it is still the legislative intent to encourage inventions of the nature claimed in the patent. Such an encouragement is possible only when hybrid seed companies, like the ones Monsanto is going after, are still within the ambit of patent infringement. An amendment to § 3(j) may exclude both the hybrid seed companies and the farmers from patent infringement, whereas it may be legislative intent to only shield farmers.

Another concern in holding the patent valid is the impact on the price of such seed. A valid patent means, the seed companies will have to pay licencing fee to the patent owner, and it is eventually the farmer who pays for it all. However, while the Act has provisions to impact pricing, invalidation of the patent is certainly not the answer to pricing concerns. The government is and continues to regulate trait value to be paid to patent owner, and we believe is the right approach to tackle pricing concerns.

In conclusion, we believe that the subject matter as claimed doesn’t fall within the scope of excluded subject matter, and hence the validity of the patent should be upheld. The seeds produced by seed companies, and therefore the seed companies, should be within the ambit of patent infringement. Further, The Patents Act, 1970 should be amended to introduce a clause to shied certain acts of framers from patent infringement. Additionally, price control of certain farm inputs should be carried out by calibrating trait value, as is being done currently.

We hope this article was a useful read. 

Please feel free check our services page to find out if we can cater to your requirements. You can also contact us to explore the option of working together. 

Best regards – Team InvnTree   

This work is licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License